N/A N=18 Treatment

Metabolic Study of Women With Polycystic Ovary Syndrome and Sleep Apnea

Polycystic Ovary Syndrome · Obstructive Sleep Apnea

Bottom Line

View on ClinicalTrials.gov: NCT00696111 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2024

Primary outcome: Primary: Estrogen Levels — 73.3; 69.9; 61.0 pg/ml

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Depot Lupron followed by estrogen plus placebo (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: University of Chicago
Primary completion: Jun 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Estrogen Levels	73.3; 69.9; 61.0	—
PRIMARY Sleep Efficiency Measured at Baseline	93.2; 86.7; 92.3	—
PRIMARY Total Testosterone	70.5; 50.9; 45.3	—
SECONDARY Intravenous Glucose Tolerance Test	938.5; 730.6; 189.5	—

Summary

The purpose of this study is to look at the metabolic (use of energy) and hormonal features of sleep problems in women with polycystic ovary syndrome (PCOS).

Eligibility Criteria

Inclusion Criteria

Clinical diagnosis of PCOS
Obese (BMI of at least 30 kg/m2)

Exclusion Criteria

Diagnosis of nonclassic 21-hydroxylase deficiency, Cushing syndrome, hypothyroidism, or significant elevations in prolactin
Taking steroid preparations (including oral contraceptives), medications known to alter insulin secretion and/or action, or medications known to influence sleep during the 2 months prior to starting the study
Positive pregnancy test
Diagnosis of diabetes mellitus
Hypertension (systolic > 140 mmHg and/or diastolic > 90 mmhg) not well-controlled on stable medication with either ACE inhibitors or diuretics
Habitual alcohol use
Excessive caffeine intake of more than 300 mg/day
Known peanut allergies, or allergies to medications used in the study
Hemoglobin < 11g/dL and/or hematocrit < 33%
Systemic illnesses, including heart, renal, liver, or malignant disease

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00696111). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.